Epidemiology of Rotavirus Infection in North India Community

Disease Burden Study and Site Preparation for Planning and Implementation of the Phase III Trials for the Oral Rotavirus Vaccine 116E

This study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.

Study Overview

• Status: Completed
• Conditions: Rotavirus Gastroenteritis

Detailed Description

Field workers conducted weekly surveillance in areas allocated to them and identified pregnant women, newborns and infants aged 9 to 12 months. Children who were eligible for participation through criteria for inclusion and exclusion in the trial were enrolled. Two cohorts were recruited, one cohort enrolled within one week of birth and followed up weekly till 1 year of age (cohort 1=100) and the second cohort enrolled at 12 months of age and followed up till 24 months of age (cohort 2=100).

Weekly contact were made by field workers for both the cohorts. At each contact cases of gastroenteritis were identified. All infants with gastroenteritis were assessed by a field worker/clinical coordinator. The child was assessed for presence of dehydration, danger signs. The field worker/clinical coordinator ensured that at least one diarrheal stool specimen was collected for each episode of gastroenteritis. Infants were treated at the study clinic or escorted to one of the identified hospitals, if required.

Caregivers of the enrolled infants were explained the signs and symptoms of suspected intussusception, dehydration and danger signs that require hospital referral and were given the option to seek care from the study clinic or from one of the identified hospitals in the vicinity.

Stool specimens were collected in all diarrheal episodes. In a subset of 30 children who were identified early in a diarrheal episode and who shed rotavirus, multiple stool specimens were collected in order to assess duration of shedding of rotavirus during a natural infection.

The study was also designed to collect information on data essential for planning and implementation of phase III trials pertaining to trial logistics, data collection tools and validity of questions including those in the Vesikari score.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110016
      • Society for Applied Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study was conducted in Delhi at Govindpuri-Tigri-Dakshinpuri, Tuglakabad and Sangam Vihar.

Description

Inclusion Criteria:

• Parents/guardian consent for participation and are able to understand study procedures
• Healthy infant aged ≤ 1 week - cohort I, children aged 12 months (+14 days)-Cohort 2
• Absence of any illness requiring hospitalization
• No confirmed plans to move in the next 12 months

Exclusion Criteria:

• Participating in any other trial
• Any signs or symptoms of active sepsis, pneumonia, meningitis or any other disease requiring hospitalization
• Known case of immunodeficiency disease, known HIV positive
• Known case of chronic gastrointestinal disease
• Any other conditions which in the judgment of the investigator warrant exclusion(e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 1; Cohort 1: Infants enrolled at ≤1 week and followed up weekly till one year of age.
Cohort 2; Cohort 2: Infants enrolled at 12 months and followed up weekly till they are aged 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease burden	All episodes of gastroenteritis: rotavirus gastroenteritis; rotavirus gastroenteritis by the G and P types; severe gastroenteritis; severe rotavirus gastroenteritis; severity score of all episodes of gastroenteritis Rates of hospitalization in the above categories Proportion requiring rehydration therapy in all the above categories	1 year
Duration of rotavirus shedding	To ascertain the duration of rotavirus shedding after an episode of rotavirus gastroenteritis	1 year
Rotavirus genotypes	To identify genotypes of rotavirus	1 year
Data collection for planning and implementation of phase III trials	To collect information on data essential for planning and implementation of phase III trials pertaining to trial logistics, data collection tools and validity of questions including those in the Vesikari score.	1 year

Collaborators and Investigators

• Sponsor: Society for Applied Studies
• Collaborators: Ministry of Science and Technology, India; National Institute of Immunology, New Delhi

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 12, 2012

Study Record Updates

• Last Update Posted (Estimate): January 12, 2012
• Last Update Submitted That Met QC Criteria: January 9, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Disease burden; Rotavirus gastroenteritis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: SAS/BBIL/07/2008